India to Enforce Stricter Regulations on Clinical Trials

The head of India’s Central Drug Standards Control Organization (CDSCO), Surinder Singh, recently announced that the government will be bringing in more stringent regulations for clinical trials within the next few years. CDSCO recently created a team of industry and NGO experts to develop a set of new guidelines, which should be in place by the end of 2009. The booming clinical trial industry in India is projected to be worth US$1 billion in 2010.

CDSCO will soon require mandatory registration of all contract research organizations (CROs) and ongoing clinical trials in India. The registry of firms and trials will be publicly accessible.

CDSCO plans to hire 94 new inspectors to monitor clinical trials and medical devices. A large proportion of the new inspectors will work on clinical trials only. CDSCO is currently training its officials with the help of the World Health Organization (WHO).

Indian officials are also planning surprise visits to clinical trial sites in the near future to ensure their compliance with safety and quality regulations. Trials that are found to violate these regulations will be suspended.